Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M923 · 3 trials · 4 indications
| Name | Type | Description |
|---|---|---|
| M923 | BIOLOGICAL | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
| Autoinjector | DEVICE | Subcutaneous administration |
| Humira | BIOLOGICAL | Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α) |
M923 is an investigational monoclonal antibody being studied for chronic plaque psoriasis, rheumatoid arthritis, and in healthy subjects for pharmacokinetic and safety assessments. It is being developed as a potential biosimilar to Humira (adalimumab), though it is not yet approved and remains in clinical development.
M923 targets tumor necrosis factor (TNF), a key inflammatory cytokine involved in autoimmune diseases. By binding to TNF, it is designed to block its activity, which is relevant for conditions like chronic plaque psoriasis and rheumatoid arthritis. This mechanism is consistent with its development as a Humira biosimilar.
M923 is being developed by Johnson & Johnson, a company publicly traded under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety, efficacy, and pharmacokinetics in various patient populations.
M923 is in Phase 3 clinical development. It has completed Phase 3 studies in chronic plaque psoriasis and rheumatoid arthritis, as well as a Phase 1 study in healthy subjects. However, it is still investigational and has not received FDA approval.
M923 has completed three clinical trials: NCT02581345, a Phase 3 study in chronic plaque psoriasis; NCT02675023, a Phase 1 pharmacokinetic and safety study in healthy subjects; and NCT02722044, a Phase 3 usability study in rheumatoid arthritis. All trials are completed, with no active trials currently listed.
M923 is being developed as a biosimilar to Humira (adalimumab), meaning it is intended to be highly similar to Humira in terms of safety, efficacy, and pharmacokinetics. However, it is a distinct product and is not yet approved for marketing.